Regulatory Roundup: WHO Releases Draft Guideline For Production And Control Of Specified Starting Materials.

Regulatory Roundup

According to a release from Rx-360, the international pharmaceutical supply-chain consortium, the World Health Organization has released for comment a draft guideline for the production and control of specified starting materials. The draft, currently released to only a specified audience, defines starting materials as “any substance which is primarily or mainly used as a starting material for the production of an API [active pharmaceutical ingredient], but which itself could be used directly as an API” and notes that the specified starting material should therefore “conform to the existing monograph in a recognized pharmacopeia.” If the material is to be used for API production, however, then the “quality attributes and specifications should be determined by the API manufacturer” and the product’s intended use, according to RX-360’s release on the guideline. Quality control for starting materials should include test for impurities, isomers, residual solvents, and other impurities and take a risk-based approach. The consortium has a full summary on its website.